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THE Cover
PURGO BIOLOGICS Inc. · Model BP3-1530 · UDI-DI 08800039003759
NPL
Prescription
1
510(k) clearances
191
Adverse events
11
Recalls
55
Facilities
Description
Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers from penetrating the damaged area. THE Cover induces cell proliferation from the periodontal ligament and alveolar bone.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-11-05 | Collagen Matrix Inc | The products may have been packaged with an incorrect Instructions for Use. |
| 2019-03-19 | Collagen Matrix, Inc. | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box |
| 2016-12-02 | Biom'up | Lack of sterility assurance |
| 2012-02-28 | Kensey Nash Corp | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in pa |
| 2012-02-28 | Kensey Nash Corp | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in pa |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.